IntelGenx beginning patient screening in Phase 2a Montelukast VersaFilm trial in AD
IntelGenx (TSXV:IGX; OTCQX:IGXT) announced that patient recruitment would begin for a Phase 2a study with Montelukast VersaFilm in patients with mild-to-moderate Alzheimer’s Disease (AD).
Two research sites in Toronto and Halifax, NS will be open for patient enrolment on Sept. 26, with additional sites planning to begin patient screening in the near future.
The double-blind, placebo controlled Phase 2a proof-of-concept study will enroll approximately 70 subjects with mild-to-moderate AD across eight Canadian research sites.
The primary study objectives will be to evaluate the safety, feasibility, tolerability, and efficacy of montelukast buccal film following daily dosing for 26 weeks.
“As treatment options are limited, and with no approved drugs being disease modifying, there is no question that AD remains an area of significant unmet medical need,” Dr. Horst Zerbe, president and CEO of IntelGenx, said in a statement.
“If proven to be effective, montelukast has the potential to be a truly impactful in the treatment of this terrible disease,” he added.
The FDA approved montelukast in 1997 for the treatment of asthma and seasonal allergic rhinitis. IntelGenx is repurposing montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug into an oral film-based product.